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    Swiss Pharmacopoeia

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    The document discusses key aspects of the European Pharmacopoeia (Ph.Eur.) and Swiss Pharmacopoeia (Ph.Helv.), including that the Ph.Eur. and Ph.Helv. are the legally binding pharmacopoeias in Switzerland, the Ph.Eur. was published in January 2012 and the Ph.Helv. was published in July 2010 with an update planned for this year, and both are updated multiple times per year and decade respectively. It also notes that the pharmacopoeias provide specifications for APIs, herbal products, biologicals, and traditional medicines.

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    Swiss Pharmacopoeia

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    param540
    127 views12 pages
    The document discusses key aspects of the European Pharmacopoeia (Ph.Eur.) and Swiss Pharmacopoeia (Ph.Helv.), including that the Ph.Eur. and Ph.Helv. are the legally binding pharmacopoeias in Switzerland, the Ph.Eur. was published in January 2012 and the Ph.Helv. was published in July 2010 with an update planned for this year, and both are updated multiple times per year and decade respectively. It also notes that the pharmacopoeias provide specifications for APIs, herbal products, biologicals, and traditional medicines.

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    Difference between Swiss medic

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    Swiss_Pharmacopoeia

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    The document discusses key aspects of the European Pharmacopoeia (Ph.Eur.) and Swiss Pharmacopoeia (Ph.Helv.), including that the Ph.Eur. and Ph.Helv. are the legally binding pharmacopoeias in Switzerland, the Ph.Eur. was published in January 2012 and the Ph.Helv. was published in July 2010 with an update planned for this year, and both are updated multiple times per year and decade respectively. It also notes that the pharmacopoeias provide specifications for APIs, herbal products, biologicals, and traditional medicines.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    127 views12 pages

    Swiss Pharmacopoeia

    Uploaded by

    param540
    The document discusses key aspects of the European Pharmacopoeia (Ph.Eur.) and Swiss Pharmacopoeia (Ph.Helv.), including that the Ph.Eur. and Ph.Helv. are the legally binding pharmacopoeias in Switzerland, the Ph.Eur. was published in January 2012 and the Ph.Helv. was published in July 2010 with an update planned for this year, and both are updated multiple times per year and decade respectively. It also notes that the pharmacopoeias provide specifications for APIs, herbal products, biologicals, and traditional medicines.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 12

    1|

    1. Name of pharmacopoeia

     European Pharmacopoeia
    (Pharmacopoea Europaea – Ph.Eur.)

     Additional: Swiss Pharmacopoeia


    (Pharmacopoea Helvetica – Ph.Helv.)

    2|
    2. Pharmacopoeia referred to in national/
    regional legislations

     Legally binding Pharmacopoeia in Switzerland:


    Ph.Eur. + Ph.Helv.

     Legal basis is Swiss law

     Art. 4, 8 and 52 of the Law on Therapeutic Products

     Ordinance regulating the issue of the


    Pharmacopoeia by Swissmedic

     Ordinance putting the Pharmacopoeia into force

    3|
    National/regional legislation includes
    reference to other

     national pharmacopoeia: Swiss Pharmacopoeia

     regional pharmacopoeia(s): European Pharmacopoeia

     international pharmacopoeia: No

    4|
    4. Publication of latest edition

     European Pharmacopoeia: 1st January 2012 (Ph.Eur. 7.3)

     Pharmacopoeia Helvetica: 1st July 2010 (Ph.Helv. 10.3)

     New edition planned for this year (Ph.Helv. 11.0)

    5|
    5. Update frequency

     Ph.Eur.: 3 times per year

     Ph.Helv.: Every 1-2 years

    6|
    6. For which products does the pharmacopoeia
    provide specifications?

      APIs,
      herbal products,
      biologicals,
      traditional medicines,
      hospital and retail pharmacy preparations
    (Ph.Helv. only)

    7|
    7. Number of texts included in the pharmacopoeia

     Ph.Eur.
    –  More than 2’000 monographs
    –  More than 300 general
    methods of analysis

     Ph.Helv.
    –  Approximately 135 monographs

    Graphic illustration “Scope Ph. Eur. Monographs” taken from EDQM Annual Report 2010

    8|
    8. Collaboration with and/or being part of a (different)
    national/regional pharmacopoeia

    Participation in elaboration of European Pharmacopoeia


    •  Based on a convention (contract between states,
    signed by CH)
    •  Ph.Eur. texts are to be implemented in Swiss law

    International collaboration
    •  No direct collaboration outside Europe
    •  Indirect collaboration via EDQM‘s participation in
    PDG
    •  Results of this process are incorporated in Ph.Eur.

    9|
    9. Publication of harmonized pharmacopoeial
    texts within the pharmacopoeia

     Harmonization between Ph.Eur., USP and JP

     Harmonized texts are published in Ph.Eur.

    10 |
    10. Interaction with stakeholders,
    including regulators

    Stakeholders from industry, universities, authorities and


    hospital and retail pharmacies are organized in expert
    groups for:
    •  Complementary medicine (TCM, Homoeopathy)
    •  Phytochemistry (herbals)
    •  Chemical substances
    •  Pharmaceutical technology
    •  Biological products (vaccines, blood products)

    11 |
    11. Strategy for the future

     Active participation in the activities of the Ph.Eur.


    These are based on a legally binding mandate
    (Ph.Eur. Convention)

     An extension of pharmacopoeial activities beyond the


    participation in the activities of the Ph.Eur. would require
    a legal mandate

    12 |

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